Health Experts Call For Flu Drug Warning

The most widely used flu drug in the world should carry a stronger warning label about psychiatric problems seen in a handful of patients, government advisers said Tuesday.

A panel of experts to the Food and Drug Administration voted 8 to 6 that drug maker Roche change the warning label for Tamiflu, which has been used by 48 million patients since its launch in 1999.

The drug's label already mentions reports of delirium and self-injury, primarily among children in Japan, but some of FDA's experts suggested the language should mention that several patients have died as a result of these abnormal behaviors.

While a majority of FDA's advisers agreed stronger warnings were needed, they stressed that the psychiatric problems are rare and that it is unclear whether they are caused by the drug or by the flu itself. Several panelists said labeling should point out that similar deaths have occurred in flu patients not taking medication.

Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan. Five children there have died after "falling from windows or balconies or running into traffic," according to FDA.

Japan accounts for two thirds of the $2.4 billion global market for Tamiflu because doctors there almost always prescribe drugs to treat flu symptoms.

Japanese health authorities are scheduled to hold their own meeting on Tamiflu's safety next month.

Basel, Switzerland-based Roche on Tuesday presented its own analysis of more than 150,000 patients that showed no connection between Tamiflu and increased risk of psychiatric problems.

"Emerging evidence suggests that influenza itself may cause neuropsychiatric adverse events," Roche said in a statement.

The company said Tuesday it agreed with panelists that any new labeling should mention that the adverse events are rare.

FDA released updated safety information on Tamiflu and a similar GlaxoSmithKline anti-flu drug Relenza last week. The agency's advisers recommended strengthening warnings on Relenza as well.

While no deaths have been connected with the drug, patients have reported similar problems to those seen with Tamiflu. The drug's labeling currently does not mention such reports.

The drug from British drug maker Glaxo accounts for less than one percent of the U.S. market for antiviral flu drugs, which is dominated by Tamiflu, according to health statistics firm IMS Health.

FDA's advisers are scheduled to review the safety of several drugs when used in children during the three-day meeting.

FDA is not required to follow the recommendation of its panel members, though it usually does.